BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULKAMID

    MDR report key: 24713348 · Received March 30, 2026

    Report

    Report Number
    2124215-2026-16913
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    December 9, 2025
    Report Date
    March 27, 2026
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    UDI-DI
    10810005340509
    PMA / PMN Number
    P170023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABSENCE OF TREATMENT. BLOCK H11: WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. SINCE THE INVESTIGATION FINDINGS DO NOT CLEARLY CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED PROBLEM WITH THE DEVICE, THE INVESTIGATION CONCLUSION CODE SELECTED FOR THIS COMPLAINT IS UNABLE TO EXCLUDE DEVICE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE BULK AMID INJECTION, THE CLINICAL TEAM ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE BULKING MATERIAL THROUGH THE NEEDLE. DURING THIS PROCESS, A LEAK OF MATERIAL WAS OBSERVED DUE TO A FAILURE OF THE LUER-LOCK CONNECTION BETWEEN THE NEEDLE AND THE SYRINGE. THE PHYSICIAN WAS ABLE TO DELIVER APPROXIMATELY ONE FULL TUBE OF MATERIAL. ALTHOUGH PARTIAL DELIVERY WAS ACHIEVED, THE TREATMENT WAS NOT CONSIDERED OPTIMAL. ACCORDING TO THE PHYSICIAN, TWO DEVICES EXHIBITED THE ISSUE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF THE PROCEDURE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775268 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50050 AU2F242001 10810005340509

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female